USA – FDA works to advance real-world data collection in pregnancy and lactation

The US Food and Drug Administration (FDA) is working on ways to facilitate greater use of real-world data (RWD) to help understand the safety and efficacy of medications used during pregnancy and lactation.

Despite the widespread use of prescription and over-the-counter medications by pregnant and lactating women, there is often little or incomplete information to guide decisions about starting and stopping medications or changing doses.

“Although the lack of scientific data prevents us from understanding the true risk for most medications in pregnancy, there is research that suggests women overestimate the risk of taking medication and decide against use when their own research yields conflicting information on safety,” Sara Head, PhD, of the FDA Office of Women’s Health, said during a public workshop hosted by Johns Hopkins Center of Excellent in Regulatory Science and Innovation (JH-CERSI) and the FDA Office of Women’s Health…